Measuring Brain Tumor Consistency Using Magnetic Resonance Elastography

Study Purpose

This clinical trial tests whether a new imaging technique called magnetic resonance elastography (MRE) is useful in determining the consistency of brain tumors and whether this could be used to guide surgical planning and choice of approach (the type of surgery that is needed) for patients with brain tumors. Comparing MRE with the typical magnetic resonance imaging (MRI) scan may help researchers assess the quality, reliability, and diagnostic utility of this scan when evaluating brain tumors.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- All patients 18 years of age or older who undergo surgical resection for brain tumor at Keck Medical Center of University of South Carolina (USC) are eligible for inclusion into this study.

Exclusion Criteria:

- Patients who cannot tolerate MRE.

- Those ineligible for MRI due to metallic implants, claustrophobia, or body habitus too large to fit in our MRI machine.

- Those not undergoing surgical resection of brain tumor.

- Children under the age of 18, pregnant women, wards of the state, and prisoners.

- There will be no exclusion of patients based on gender, racial or ethnic origin

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05516485
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Southern California
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mark S Shiroishi, MD
Principal Investigator Affiliation	University of Southern California
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Neoplasm

Additional Details

PRIMARY OBJECTIVES:

I. Examine tolerance interval of MRE measurement in kilopascals (kPa) and associated distribution of percent stiff (hard) and soft tumors above the higher limit and below the lower limit.

II. Through machine learning with MRE and clinical/demographic factors, to identify diagnostic thresholds in separating stiff tumor from soft tumor.

OUTLINE: Patients undergo MRE scan over 25 minutes before surgery at the time of standard of care pre-operative MRI scan. On the day of surgery, the surgeon grades and records tumor consistency/stiffness during the operation and afterwards.

Arms & Interventions

Arms

Experimental: Diagnostic (MRE, tumor grading)

Patients undergo MRE scan over 25 minutes before surgery at the time of standard of care pre-operative MRI scan. On the day of surgery, the surgeon grades and records tumor consistency/stiffness during the operation and afterwards.

Interventions

Other: - Assessment

Undergo grading and recording of tumor consistency/stiffness

Device: - Magnetic Resonance Elastography

Undergo MRE

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

USC / Norris Comprehensive Cancer Center, Los Angeles, California

Status

Address

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Site Contact

Mark S. Shiroishi

[email protected]

323-865-9914

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